Condition category
Surgery
Date applied
07/04/2018
Date assigned
25/04/2018
Last edited
23/04/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
The pain following heart surgery is mostly associated with sternotomy (surgical procedure to divide the sternum), pericardiectomy (removal of the membrane around the heart), chest tube insertion, and the removal of a vein from a patient's leg. Traditionally, intravenous opioids are used for pain management after heart surgery.
However, their use is associated with side effects, such as nausea, vomiting, itching, urinary
retention, intestinal paresis, and respiratory depression. Long-acting opioids administered after surgery postpone the removal of the ventilation tube in the windpipe (extubation) due to increased sedation and respiratory depression (inadequate slow and shallow breathing).
A combination of nonsteroidal anti-inflammatory drugs (NSAID) and opioid analgetics has been recommended for pain relief after major surgeries. The need of opioid analgesics can be reduced by using NSAIDs, thus also reducing the side effects of opioid analgesics, especially nausea and vomiting. The combination of NSAID and opioid analgesics contributes to an earlier extubation and patient mobilisation leading to an early discarge from the ICU.
The aim of the study is to confirm whether NSAID diclofenac decreases the use of opioid analgesics following cardiac surgery during the first 20 hours after surgery.

Who can participate?
Adults aged 20 – 85 years undergoing elective cardiac surgery

What does the study involve?
Participants are randomly allocated to one of two groups. Those in the first group receive intravenous Diclofenac after cardiac surgery, whilst those in the control group receive intravenous saline. Participants are followed up for 20 hours after surgery.

What are the possible benefits and risks of participating?
There are no specific benefits or risks for those taking part in the study.

Where is the study run from?
University Medical Centre Maribor (Slovenia)

When is the study starting and how long is it expected to run for?
May 2016 to December 2018

Who is funding the study?
University Medical Centre Maribor (Slovenia)

Who is the main contact?
Mrs Irena Osojnik (Scientific)
irena.ogrizek@guest.arnes.si

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Irena Osojnik

ORCID ID

Contact details

University Medical Centre Maribor
Ljubljanska ulica 5
Maribor
2000
Slovenia
+ 386 51 243 260
irena.ogrizek@guest.arnes.si

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

0120-430/2016-2

Study information

Scientific title

The effect of diclofenac on bleeding, platelet function, and the use of opiates following coronary artery bypass graft

Acronym

Study hypothesis

The purpose of the study is to establish whether using diclofenac after a coronary artery bypass graft (CABG) with extracorporeal circuit decreases the consumption of opioid analgesics and their side effects. It also aims to establish whether diclofenac disrupts the platelet function and consequently increases bleeding and transfusion of blood and blood products after cardiac surgery.

Ethics approval

1. Commission of the Republic of Slovenia for Medical Ethics (Komisija Republike Slovenije za medicinsko etiko), 22/08/16, ref: 0120-430
2. Republic of Slovenia National Medical Ethics Committee (NMEC) 10/08/2016, ref: 2016-2

Study design

Single-centre prospective randomised controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Cardiac surgery

Intervention

After cardiac surgery, participants are randomised to one of two treatment groups using coin randomisation.
1. The treatment group receive an intravenous infusion of 75 mg diclofenac (250 ml Neodolpasse) within 90 minutes to three hours after cardiac surgery, and again after 12 hours.
2. The control group receive an infusion of 250 ml of saline (0.9% NaCl) within 90 minutes to three hours after surgery, and again after 12 hours.

Both groups are followed up 20 hours after surgery.
Both groups receive intravenous bolus piritramid 0.05 mg/kg body weight every six hours for postoperative pain relief. In addition to basal pain relief the patients receive additional piritramid 0.025 mg/kg on request by means of nurse controlled analgesia to achieve adequate analgesia (NRS ≤ 3).

Intervention type

Drug

Phase

Drug names

Diclofenac

Primary outcome measure

1. Pain is measured using the NRS (numerical rating scale) for pain assessment at 1 hour intervals until 20 hours after surgery
2. The use of piritramide is recorded within the first 20 hours after surgery
3. The use of blood and blood product is recorded within the first 20 hours after surgery

Secondary outcome measures

1. Heamodynamic data (invasive blood pressure and heart rate) is measured using Phillips MX 800 monitor at 1 hour intervals until 20 hours after surgery
2. Sternal drain blood loss is measured using Sternal drainage system Atrium at 1 hour intervals until 20 hours after surgery
3. Time to extubation and time of ICU stay is recorded.
4. Unfavourable side effects are recorded during the ICU stay

Overall trial start date

01/05/2016

Overall trial end date

30/12/2018

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Adult aged 20 - 85 years
2. Operated for elective cardiac surgery using extracorporeal circuit

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60

Participant exclusion criteria

1. History of peptic ulcer disease, gastointestinal bleeding
2. Renal and liver insufficiency
3. Allergy for nonsteroidal analgetics
4. Increased bleeding during surgery
5. Increased bleeding after surgery, as defined by the chest tube drainage of more than 300 ml per hour during the first 3 hours after surgery.

Recruitment start date

30/10/2016

Recruitment end date

30/08/2018

Locations

Countries of recruitment

Slovenia

Trial participating centre

University Medical Centre Maribor
Maribor
+386 51 243 260
Slovenia

Sponsor information

Organisation

University Medical Centre Maribor

Sponsor details

Medical Research Department
Ljubljanska ulica 5
Maribor
2000
Slovenia
+386 321 1000
irena.osojnik@ukc-mb.si

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

University Medical Centre Maribor

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication of results in Medical Journals.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request.

Additional documents are available upon request from the author.

Intention to publish date

30/06/2019

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes